Non-Alcoholic Fatty Liver DiseaseID LIVERNCT04666402
Integrated Diagnostics for Early Diagnosis of Liver Disease
An observational study of Non-Alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is an observational study that will explore the hypothesis that by combining data from patients with liver disease with novel blood biomarkers, single nucleotide polymorphism (SNP) analysis and faecal microbiome analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, Alcoholic Liver Disease
- What is being tested?
- Blood tests for Single Nucleotide Polymorphisms, Faecal microbiome analysis and Serum for diagnostic biomarkers
- How many people
- 1,200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Oct 2020to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending Community Liver Assessment Clinic within Manchester with deranged liver function tests, fatty liver on ultrasound or a history of alcohol excess
Who may be able to join
- All patients referred to Community Liver Assessment Clinic.
- Male or female > 18 years of age.
- Females will be non-pregnant and non-lactating.
Who cannot join
- Age < 18 years.
- Pregnancy/breast-feeding. Women of childbearing potential (not >2 years post- menopausal and/or not surgically sterilised) must have a negative blood serum pregnancy test.
- Isolated bilirubinaemia.
- Known pre-existing liver disease.
- Acutely unwell.
- Suspected malignancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M13 9WL
Varinder Athwal, Varinder.athwal@manchester.ac.uk
About this study
This is an observational study that will explore the hypothesis that by combining data from patients with liver disease with novel blood biomarkers, single nucleotide polymorphism (SNP) analysis and faecal microbiome analysis. The Investigators will improve diagnosis of liver fibrosis compared to the current available diagnostic tools.
Read the detailed description
Liver disease is a silent epidemic. Four in ten people in the North West are likely to have evidence of liver disease. A small but significant proportion of these patients develop scarring, leading to end-stage cirrhosis. All too frequently this is detected in very advanced stages, where treatment cannot reverse the condition. It is one of the UK's largest health challenges. At present clinicians use a wide range of single tests that individually struggle to identify disease and high-risk patients early.
The Investigators are implementing a new pathway for the assessment of patients with abnormal liver blood tests or high risk for liver disease. This novel pathway will allow assessment of patients in Community Liver Assessment Clinics (CLAC) with the expectation that only 20% of patients assessed would need to be seen in secondary care for further assessment. The investigators expect, to be assessing, 750 patients per year in this pathway. This pathway will bring together a large group of patients with liver disease. As part of the clinical assessment the investigators will be undertaking investigations to diagnose disease and assess extent. This will generate significant information, that the investigators currently use in isolation to make the aforementioned assessments. In this study, the investigators would like to bring together all this data into a curated database. To this end, the investigators would offer all patients who attend the CLAC for clinical need to enrol into the study. This would generate a database to combine all data, alongside some other, non-invasive tests, done alongside routine clinical tests.
This project will address this lack of answers by teaming up with innovative companies to make software that joins together a wide range of different tests to make an algorithm to detect disease earlier.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, Alcoholic Liver Disease, Liver Fibroses
- Being tested
- Blood tests for Single Nucleotide Polymorphisms, Faecal microbiome analysis, Serum for diagnostic biomarkers
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases, Alcoholic, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood tests for Single Nucleotide PolymorphismsOther
This extra test would be performed on participants assessed in the specialist liver clinic. This test would require an extra 5ml of blood to be taken at the time of routine blood tests for clinical purposes.
Faecal microbiome analysisDiagnostic test
This test will be undertaken for all participants who give consent and are assessed through the new liver care pathway, in the community liver assessment clinic. All participants will be given the equipment to take a stool sample at the time of presentation at the community liver assessment clinic and asked to return the sample to the clinic. The sample will be processed to remove genetic material so the microbiome can be identified.
Serum for diagnostic biomarkersDiagnostic test
Blood samples will be taken alongside blood taken for clinical assessment. In total, an extra 5ml of blood. These samples will be used to explore novel blood biomarkers using ELISA and mass-spectroscopy techniques in the University of Manchester.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in patient numbers requiring secondary care appointments for the investigation of advanced liver fibrosis.
Our project aims to identify patients with liver fibrosis in the community and only those with evidence of advanced fibrosis or cirrhosis being triaged on into secondary care hepatology services.
Measured: At study completion; within 3 years
Secondary outcomes (1)
To define the metrics involved in the diagnosis of advanced liver fibrosis or cirrhosis
Through combining the data from basic clinical bloods such as LFTs, non-invasive scoring systems such as FIB-4 and NAFLD fibrosis scores along with the novel biomarkers, we will use this data through AI to develop algorithms that will aid the diagnosis of advanced fibrosis/cirrhosis.
Measured: At study completion; Within 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start21 Oct 2020
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Manchester, University of Nottingham, Innovate UK
- Responsible party
- Sponsor
- Investigators
- Varinder Athwal, Principal investigator, Manchester University NHS Foundation Trust/Manchester University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666402
- Sponsor's protocol ID
- B00907
- Acronym
- ID LIVER
- Status last verified
- Feb 2026
- First submitted
- 21 Oct 2020
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Diagnostics for Early Diagnosis of Liver Disease
- ClinicalTrials.gov ID
- NCT04666402
- Acronym / sponsor ID
- ID LIVER / B00907
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, Alcoholic Liver Disease, Liver Fibroses
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- University of Manchester, University of Nottingham, Innovate UK
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study that will explore the hypothesis that by combining data from patients with liver disease with novel blood biomarkers, single nucleotide polymorphism (SNP) analysis and faecal microbiome analysis. The Investigators will improve diagnosis of liver fibrosis compared to the current available diagnostic tools.
Detailed description
Liver disease is a silent epidemic. Four in ten people in the North West are likely to have evidence of liver disease. A small but significant proportion of these patients develop scarring, leading to end-stage cirrhosis. All too frequently this is detected in very advanced stages, where treatment cannot reverse the condition. It is one of the UK's largest health challenges. At present clinicians use a wide range of single tests that individually struggle to identify disease and high-risk patients early.
The Investigators are implementing a new pathway for the assessment of patients with abnormal liver blood tests or high risk for liver disease. This novel pathway will allow assessment of patients in Community Liver Assessment Clinics (CLAC) with the expectation that only 20% of patients assessed would need to be seen in secondary care for further assessment. The investigators expect, to be assessing, 750 patients per year in this pathway. This pathway will bring together a large group of patients with liver disease. As part of the clinical assessment the investigators will be undertaking investigations to diagnose disease and assess extent. This will generate significant information, that the investigators currently use in isolation to make the aforementioned assessments. In this study, the investigators would like to bring together all this data into a curated database. To this end, the investigators would offer all patients who attend the CLAC for clinical need to enrol into the study. This would generate a database to combine all data, alongside some other, non-invasive tests, done alongside routine clinical tests.
This project will address this lack of answers by teaming up with innovative companies to make software that joins together a wide range of different tests to make an algorithm to detect disease earlier.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending Community Liver Assessment Clinic within Manchester with deranged liver function tests, fatty liver on ultrasound or a history of alcohol excess
Key inclusion criteria (3 listed)
- All patients referred to Community Liver Assessment Clinic.
- Male or female > 18 years of age.
- Females will be non-pregnant and non-lactating.
Key exclusion criteria (6 listed)
- Age < 18 years.
- Pregnancy/breast-feeding. Women of childbearing potential (not >2 years post- menopausal and/or not surgically sterilised) must have a negative blood serum pregnancy test.
- Isolated bilirubinaemia.
- Known pre-existing liver disease.
- Acutely unwell.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood tests for Single Nucleotide PolymorphismsThis extra test would be performed on participants assessed in the specialist liver clinic. This test would require an extra 5ml of blood to be taken at the time of routine blood tests for clinical purposes. | Other | – |
| Faecal microbiome analysisThis test will be undertaken for all participants who give consent and are assessed through the new liver care pathway, in the community liver assessment clinic. All participants will be given the equipment to take a stool sample at the time of presentation at the community liver assessment clinic and asked to return the sample to the clinic. The sample will be processed to remove genetic material so the microbiome can be identified. | Diagnostic test | – |
| Serum for diagnostic biomarkersBlood samples will be taken alongside blood taken for clinical assessment. In total, an extra 5ml of blood. These samples will be used to explore novel blood biomarkers using ELISA and mass-spectroscopy techniques in the University of Manchester. | Diagnostic test | – |
Primary outcome
Reduction in patient numbers requiring secondary care appointments for the investigation of advanced liver fibrosis.
Time frame: At study completion; within 3 years
Our project aims to identify patients with liver fibrosis in the community and only those with evidence of advanced fibrosis or cirrhosis being triaged on into secondary care hepatology services.
1 secondary outcome
To define the metrics involved in the diagnosis of advanced liver fibrosis or cirrhosis
Time frame: At study completion; Within 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Varinder Athwal principal investigator
Manchester University NHS Foundation Trust/Manchester University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Varinder Athwal (0161 291 5354, Varinder.athwal@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in patient numbers requiring secondary care appointments for the investigation of advanced liver fibrosis. (time frame: At study completion; within 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.